BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2517915 · Received April 5, 2012

    Report

    Report Number
    2531779-2012-02821
    Event Type
    Death
    Date Received
    April 5, 2012
    Date of Event
    December 30, 2011
    Report Date
    March 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. AN EZPRIME OPERATION WAS PERFORMED WITH NO DIFFICULTIES, AND THE UNITS REMAINING WERE CORRECTLY CALCULATED AND RECORDED IN THE PUMP HISTORY. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. A REVIEW OF THE PUMP HISTORY INDICATED TIME AND DATE DEFAULTING TO FACTORY SETTINGS WHICH COULD NOT BE DUPLICATED ON INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS IN RESPONSE TO AN ANIMAS MAILING AND STATED THAT THE PATIENT HAD DIED AT HOME ON (B)(6) 2011. THE REPORTER STATED THAT THE PATIENT HAD A HISTORY OF LUNG CANCER FOR 30 YEARS AND THAT THE PATIENT WAS USING THE PUMP FOR SANDOSTATIN INFUSION. THE REPORTER STATED THAT THE PATIENT'S DEATH WAS NOT RELATED TO PUMP USE, AND THAT THE CAUSE OF DEATH LISTED ON THE DEATH CERTIFICATE WAS PULMONARY CARDIAC ARREST AND END STAGE LIVER FAILURE. THIS INCIDENT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: EVEN THOUGH THE PATIENT'S CAUSE OF DEATH WAS UNRELATED TO DIABETES, THE PATIENT WAS KNOWN TO HAVE USED THE INSULIN PUMP TO DELIVER A DRUG THAT IS NOT APPROVED FOR USE IN THIS DEVICE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death